Nocturia and other urinary frequency disorders affect a significant portion of the human population. Patients with nocturia experience interruption in sleep due to the need to get up during the night to urinate. Patients suffering from overactive bladder often experience urge incontinence, urgency of urination, and higher urinary frequency. Overactive bladder can be caused by uncontrolled contractions of the bundles of smooth muscle fibers forming the muscular coat of the urinary bladder (the detrusor muscle) during the filling phase of the bladder and is more prevalent in elderly adults.
Compositions and methods for treating nocturia and other urinary frequency disorders have been described. For example, U.S. Pat. Nos. 7,579,321; 7,799,761; and 8,143,225 describe pharmaceutical compositions and methods using a low dosage of desmopressin. U.S. patent application publication US 2009/0042970 describes treating nocturia and other urinary frequency disorders using, for example, transdermal administration of desmopressin. Also, U.S. patent application publication US 2012/0015880 describes treating nocturia and other urinary frequency disorders using, for example, intranasal administration of desmopressin.
One of the challenges in treating nocturia and other urinary frequency disorders using desmopressin is achieving a therapeutic, but non-toxic, blood plasma concentration of desmopressin. Administering a dose of desmopressin that is too large can have severe side effects, such as hyponatremia potentially resulting in seizures or death of the patient. As such, the need exists for compositions and methods which have improved safety profiles and/or improved efficacy using a lower dosage of desmopressin. The present invention addresses this need and provides other related advantages.